QC Investigation Support Specialist (1 of 4)

Johnson & Johnson

4.2

(92)

Raritan, NJ

Why you should apply for a job to Johnson & Johnson:

  • Ranked as one of the Best Companies for Women in 2020
  • 4.2/5 in overall job satisfaction
  • 4.2/5 in supportive management
  • 71% say women are treated fairly and equally to men
  • 88% would recommend this company to other women
  • 85% say the CEO supports gender diversity
  • Ratings are based on anonymous reviews by Fairygodboss members.
  • Global parental leave for all new parents (maternal, paternal, adoptive or surrogacy-assisted).
  • Global exercise reimbursement.
  • Two weeks off (one of them fully paid) for volunteer work.
  • #2506231254W

    Position summary

    #CAR-T team!

    The Specialist will be responsible for leading deviations and corrective actions in support of the Quality Control (QC) testing laboratories related to the manufacturing of cell therapy products for clinical trials and commercial operations in a controlled GMP environment.

    Key Responsibilities:

    • Interview personnel within QC and provide quality insight to complete laboratory investigation reports in Trackwise.

    • Review/complete routine CAR-T manufacturing nonconformance/deviation investigations.

    • Proactively work with team members to implement effective corrective and preventive actions (CAPAs) and to ensure the timely completion of CAPAs within the laboratories.

    • Provide recommendations for the improvement of processes by working cross-functionally with multiple collaborators.

    Qualifications

    Education:

    • Minimum of a Bachelor's or equivalent University Degree required

    Experience and Skills:

    Requird:

    • Minimum two (2) years of relevant work experience

    • Experience in a Quality Control setting

    • Knowledge and understanding of current Good Manufacturing Practices (cGMP) and FDA/EU guidance related to the QC laboratory

    • Knowledge of Good Documentation Practices (GDP)

    • Proficient in performing technical writing (e.g., deviations, investigations, etc.)

    • Excellent written and verbal communication skills

    • Highly organized and capable of working in a team environment under some supervision

    Preferred:

    • Detailed knowledge of CAR-T QC test methods and related equipment

    • Familiarity with QEM (quality event management) or equivalent systems

    • Basic knowledge of Compendial (e.g., USP, EP, JP, etc.) requirements and standards

    • Experience speaking and interacting with inspectors

    • Experience with aseptic processing in biosafety cabinets and/or ISO 5 clean room

    • Knowledge of Good Tissue Practices

    Other:

    • Requires ability and flexibility to accommodate shift schedule (if needed) and unplanned overtime (including nights and weekends) on little to no prior notice

    • Requires up to 10% of domestic travel

    • The anticipated base pay range for this position is $61,000 to $97,750.

    • Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.

    • Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).

    • Employees are eligible for the following time off benefits:

    • Vacation - up to 120 hours per calendar year

    • Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year

    • Holiday pay, including Floating Holidays - up to 13 days per calendar year

    • Work, Personal and Family Time - up to 40 hours per calendar year

    Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

    For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit https://www.careers.jnj.com.

    #CAR-T

    Why you should apply for a job to Johnson & Johnson:

  • Ranked as one of the Best Companies for Women in 2020
  • 4.2/5 in overall job satisfaction
  • 4.2/5 in supportive management
  • 71% say women are treated fairly and equally to men
  • 88% would recommend this company to other women
  • 85% say the CEO supports gender diversity
  • Ratings are based on anonymous reviews by Fairygodboss members.
  • Global parental leave for all new parents (maternal, paternal, adoptive or surrogacy-assisted).
  • Global exercise reimbursement.
  • Two weeks off (one of them fully paid) for volunteer work.